WO2008006150A1

WO2008006150A1 - Bio-activity data capture and transmission

Info

Publication number: WO2008006150A1
Application number: PCT/AU2007/000950
Authority: WO
Inventors: Arthur Christopher Nicolls; Dom Evangelista
Original assignee: Citech Research Ip Pty Ltd
Priority date: 2006-07-11
Filing date: 2007-07-10
Publication date: 2008-01-17

Abstract

This invention concerns the capture of bio-activity, that is physical or physiological data captured in real-time from an active animal subject, and the transmission of that data to a base station. The invention makes use of a flexible adhesive skin patch having mounted on it at least one physical sensor able to generate data relating to one or more physical change concerning the subject in real-time, and a readout system to interrogate an implanted biodegradable passive sensor and generate data from it in real-time. An identity tag able to generate identity data. And, a transmitter to transmit the generated data to a base-station in real-time. The invention has application to humans having a range of different activity levels including highly active athletes while training or performing, military personnel, and at the other extreme handicapped or geriatric people who require monitoring. In other aspects the invention relates to methods for capturing, transmitting, receiving, processing and using the data. In further aspects the invention relates to software for performing the methods.

Description

Title

Bio-Activity Data Capture and Transmission

Technical Field This invention concerns the capture of bio-activity, that is physical or physiological data captured in real-time from an active animal subject, and the transmission of that data to a base station. The invention has application to humans having a range of different activity levels including highly active athletes while training or performing, military personnel, and at the other extreme handicapped or geriatric people who require monitoring.

In other aspects the invention relates to methods for capturing, transmitting, receiving, processing and using the data. In further aspects the invention relates to software for performing the methods.

Background Art

Physical data, such as location data, can be captured from an active human or animal subject, for instance by interrogating a Global Positioning System (GPS) receiver carried by the subject. A suitable GPS device resembles a small mobile phone carried in a latex strap which is wrapped around the upper body. The data, which is not delivered in real-time, typically has an accuracy of +/-3m.

Movement data can be captured by recording the position and movement of a subject's limbs and joints and then recording this information in 3 -dimensional space as the subject moves around. This typically involves use of camera footage combined with computer software to generate the data. There are inherent difficulties with rapid player movement, real-time delivery and distinguishing several players within a close proximity.

Physiological data, such as body temperature or heart rate, is captured using a sensor attached to the body. For instance, some gym equipment has clip-on heart rate sensors wired to the machine. These sensors provide a read-out of heart rate to the machine where it can be displayed along with the machine's settings and a timer. Core body temperature pills, that are non-biodegradable battery powered devices designed to be swallowed, are able to transmit temperature readings over a short distance, such as 0.5m. They are expelled after ingestion.

These technologies are able to capture and record bio-activity data about an active human subject for a variety of purposes, including health and fitness monitoring.

Disclosure of the Invention

The invention, in a first aspect, is apparatus for the capture and transmission of bio-activity data from an active animal subject, comprising: A flexible adhesive skin patch having mounted on it at least one physical sensor able to generate data relating to one or more physical change concerning the subject in real-time, and a readout system to interrogate an implanted biodegradable passive sensor and generate data from it in real-time; an identity tag able to generate identity data; and, a transmitter to transmit the generated data to a base-station in real-time.

This invention is able to provide accurate, real-time data about a variety of physiological or physical changes, or both, measured directly from a live subject.

The patch may further comprise at least one physiological sensor able to generate data relating to one or more physiological change in the subject in real-time.

In one application the subject may be an athlete, and the invention may be used during training or in a competitive event. The generated data may be displayed to coaching or medical staff to increase the effectiveness of training. Alternatively, or in addition, the information may be transmitted to spectators to increase their sense of participation and involvement in the event.

The invention also has application to a range of different applications, including the monitoring of military personnel, old people and animals, of which race horses are an example of current interest.

The flexible adhesive skin patch may comprise a moulded elastomer. Alternatively a surgical foam adhesive pad may be used. A major benefit of these materials is in user wearability since patches made from these materials have been found not to restrict the subject's movement or impede their performance.

The patch may be worn on the skin, under typical sports clothing, or it may be integrated into clothing, accessories or equipment carried by the subject. Cut-outs are typically made in the patch to allow electrodes mounted on the back of the patch to contact the skin. A conductive electrolyte gel on the patch electrodes provides good electrical contact with the skin surface.

The edges of the patch may include slots to allow for the escape of perspiration.

A double-sided medical grade pressure sensitive adhesive foam may be used to interface between the patch and the skin. An alternative is soft skin adhesive.

The skin patch and sensors may be fabricated in the form of a disposable single use sticking plaster.

For humans the skin patch could be attached to the torso, perhaps over the heart for best results or may be located at other parts of the body to obtain sensor data. There are a number of options for providing electrical power to the sensors and other apparatus mounted on the patch. For instance, a rechargeable lithium battery may be mounted in the patch. An alternative might be to use kinetic energy as a source of power. Another alternative may be to power the sensor from dissimilar metallic electrodes placed on the skin surface. Any known power saving techniques may be employed, including powering down selected components of the apparatus after a period of non-use.

The one or more physiological sensors may measure, for instance, one or more of the following: body temperature, including core, skin and environmental temperature; muscle activity and fatigue; perspiration rate, volume and content; body dehydration; heart rate and activity; breathing rate, depth and activity; blood oxygen, carbon dioxide, carbon monoxide and other blood gas levels; blood lactate, adrenalin, Cortisol and glucose levels; blood flow rate and blood perfusion;

Electro-cardiogram (ECG); and,

Galvanic skin response (GSR).

The one or more physical sensors may measure, for instance, one or more of: position (location); body movement,; direction of movement (up or down, left or right, posterior or anterior, as well as number of steps and cadence); body rotation; speed; acceleration and deceleration; and, impact and force of impact.

The position or location may be measured using GPS, Differential GPS, Dead Reckoning or Kalman filtering; or any combination of these techniques may be used. Hybrid methods involving the use of accelerometers and interpolation between GPS samples may be used, especially when the satellite is not visible. An option is to provide for a GPS receiver system separate from the skin patch, but that interfaces its signals with those from the skin patch at the base station.

A push button contact may also be provided on the patch as a personal distress alarm, or for acknowledgement signalling.

Similar sensors may also be used to track and measure the movement of other objects such as a ball, bat or racket head. Parameters that may be determined include the trajectory path, location, spin, rotation, impact, force of impact and altitude.

For subcutaneous injected Nano-sensors, the readout system may comprise a laser diode and optical sensor to interrogate an implanted sensor. Alternatively, the readout system includes a charge-coupled device (CCD) to provide a single wavelength light that will evoke a response from the biosensor. The response will typically be emission of an optical signal correlated to some physiological parameter, such as the lactate concentration present in the blood. The optical output may be measured using a photodiode or a CCD optical receiver.

The implanted sensor itself may comprise a part of the apparatus and may be fabricated from nano-molecular porous silicon. Alternatively, the sensor could be manufactured using an electrochemical on silicon technique, or any other suitable technique. The implanted sensor may operate by changing its reflective qualities in dependence on predetermined physiological changes. It may be able to measure any of the physiological changes mentioned above, as well as one or more of: changes in blood pH; presence of, or changes in concentration of, preselected DNA molecules; presence of, or changes in concentration of, transition metal complexes; presence of, or changes in concentration of, preselected enzymes; presence of, or changes in concentration of, preselected antigens; presence of, or changes in concentration of, preselected antibodies; presence of, or changes in concentration of, preselected proteins; presence of, or changes in concentration of, glucose; presence of, or changes in concentration of, urease; and, presence of, or changes in concentration of, ferrocene.

These biosensors may be implanted by injection or by tattoo delivery under the surface of the skin. The sensors are non-toxic and biodegradable.

The electronic identity tag may contain preset identity data, or it may be programmed with identity data before use, for instance RFID tags could be used.

An ingestible core body temperature pill may record and transmit data about physiological changes, for instance core body temperature or heart rate. An additional readout system (separate from the readout system for the passive biodegradable sensors) may be mounted on the patch for these sensors. Such as readout system will typically communicate with the core body temperature pill wirelessly using radio frequency transmissions or near field induction techniques.

Other, separate, external or internal bio monitoring devices may also be used in conjunction with the patch. For example, an ear unit comprising a infrared tympanic temperature probe that is placed in the ear canal, and an ear pulse oximeter that is placed on the ear lobe of a subject to measure tympanic temperature and oxygen saturation. Both these devices transmit information wirelessly, for instance to the patch, to an RF transmitter located behind the ear (like a hearing aid) or directly to the base station. The ear unit may further comprises a blood oxygen, lactate or glucose sensor to read the oxygen level.

Additionally, a range of other separate sensors could be deployed at chosen locations around an athlete's body, say, to monitor status or performance at those locations.

The generated data may be received from the sensors continuously, in real-time, or it may be sampled according to some predetermined protocol. For instance, different date may be sampled at different data rates. The data collected by the sensors may be processed, either on the patch or after transmission. Signal processing may clean the data from the sensors, reduce redundant data or minimise the data size.

The transmitter will typically be able to transmit the data over a 50m distance or more in a secure wireless link with a high data rate. The transmitter may use 900MHz, 2.4GHz, or any Industrial, Scientific or Medical (ISM) frequency band with direct sequence spread spectrum, frequency hopping and data encryption. Alternatively, 5.8 GHz ISM or a dedicated frequency could be used. A communications protocol may be employed to manage the transmissions, including the control of sampling, transmission rates and frequencies. Any known or future signal processing techniques may be utilised to enhance the transmissions.

The transmitter may interface with any communications network, including the Public Switched Telephone Network (PSTN), ISDN, DSL, Cable, cell phone, satellite communications networks, wireless communications networks, fixed wire networks, broadcast networks and data networks generally. The transmitter may also allow for simplex, half-simplex and full-duplex communications with the base-station.

A receiver for the transmissions could be integrated into a PDA, cell phone, laptop, data logger or similar portable device. Alternatively, the receiver could be programmed into a personal or notebook computer. The receiver could forward the transmissions to a base station, or it could be incorporated into a base station. A data repository could be used to store the data content of the transmissions. Alternatively, data could be stored in on-board memory on the patch for uploading later.

The apparatus may comprise more than one of the skin patches and a base station programmed to identify and receive data transmissions from each of them. In this case the base station may be set up with multiple users, each of which might have separate logon to ensure privacy.

The transmissions may be used for one or more of a variety of purposes, including: training, for instance of athletes; monitoring, including for performance, health and wellbeing; duty of care, for instance athlete impacts or exposure to hazardous environments or toxic substances entertainment, including sports television where one or more athletes' data may be provided in real-time as a real-time overlay or tile screen insert; Key Point Index (KPI) benchmarking; research; and direct feedback, for instance athletes may access their own transmissions. In a further aspect the invention is a method for capturing bio-activity data from an active animal subject, comprising the following steps: Collecting data from a flexible adhesive skin patch having mounted on it a combination of one or more of the following: at least one physiological sensor able to generate data relating to one or more physiological change in the subject in real-time; and, at least one physical sensor able to generate data relating to one or more physical change concerning the subject in real-time.

Interrogating an implanted biodegradable passive sensor and generate data from it in real-time.

Interrogating an identity tag able to generate identity data. And, transmitting the generated data to a base-station in real-time. In other aspects the invention relates to methods for capturing, transmitting, receiving, processing and using the data. At the base station the data is appropriately manipulated in a database, then archived and further processed as a knowledge database.

In further aspects the invention concerns software for operating the skin patch, the base station or for downstream use of the data, for example in broadcasting it.

Brief Description of the Drawings

An example of the invention will now be described with reference to the accompanying drawings, in which:

Fig. 1 is a plan view of a skin patch for the capture and transmission of bio- activity data.

Fig. 2 is a schematic diagram of a system for the capture and transmission of bio-activity data.

Fig. 3 is a screenshot of a base station screen showing the data for player 1.

Fig. 4 is a screenshot of a base station screen showing live data streams from a player.

Fig. 5 is a screenshot of a team view.

Fig. 6 is a screenshot of a player summary.

Fig. 7 is a screenshot of a spilt-screen broadcast.

Fig. 8 is a screenshot of a fatigue gauge. Fig. 9 is a diagram of a complex motion analysis system exemplifying the invention.

Best Modes of the Invention

Referring first to Fig. 1. apparatus for the capture and transmission of bio- activity data 10 will in general involve a flexible adhesive skin patch 12 shaped in the form of a conventional sticking plaster. The skin patch is made from a moulded silastic elastomer, such as MDX4-4210 medical grade silastic. Mounted on the patch 12 are the following: Physiological sensors: • three ECG sensors 20;

• a body skin temperature sensor 22; • a hydration sensor 24;

• a perspiration sensor 25;

• a blood oxygen sensor 26; And,

• a respiration sensor 28. On the reverse side of the skin patch there are holes in registration with these physiological sensors to allow them to contact the skin when the patch is applied.

Physical sensors:

• accelerometers 30 that measure both movement and the force of impacts; • a GPS receiver 32; and

• a programmable identity (Radio frequency ID or RFID) tag 34.

A readout system 40 including a miniature laser diode to interrogate an implanted biodegradable passive sensor and generate data from it in real-time. A miniature photodiode or CCD detector are used to collect the data.

A transmitter 50 and antenna 52 transmit the generated data to a base station 100 in real-time. The transmitter also receives communications from the base station 100. The transmitter is an RF communications module, in this example is an XB ee Pro module, that operates in the ISM frequency band. The transmission frequency may be 900 MHz or 2.4 GHz. The RF transmit power is 60 mW (18dBm) and has a line of sight range of 100m indoors, and 1200m outdoors.

A digital signal processor (DSP) chip 54 processes signals produced by the sensors and readout system. The DSP chip in this example is the PIC18F67J10 microcontroller which operates with a 3 volt supply. It has inbuilt analogue to digital converters to sample the sensor signals and convert them to digital signals for onward transmission. It also has inbuilt serial ports to communicate with the transmitter 50 and the GPS receiver 32. A single flexible printed circuit board is used to connect the DSP chip 54 to the other components and allows the patch to conform well to the body shape. The ECG sensors 20 use Ag/AgCl electrodes. The ECG signal received from the three sensors 20 is filtered and amplified by the DSP chip 54. The heart rate can be determined from the ECG waveform. A breathing signal is obtained from two of the ECG sensors 20 using the chest impedance method, again filtering and amplification is required before conversion to digital.

Perspiration is measured between a separate electrode and a ground electrode using galvanic skin response method.

Hydration is measured using bioimpedance analysis (BIA) based on the electrical characteristics of the patch use. The sensor measures hydration using an equation of a number of BIA parameters. Additional hydration sensors may be placed on body sites separated from the patch 10 to improve the accuracy of the measurement. Acceleration is measured using two analogue tri-axis accelerometers, such as the

ADXL278. These devices have a range of +/- 10Og. More sensitive devices may be used for sports where better resolution is required such as tennis.

A rechargeable lithium battery 60 provides a regulated 5 volt or 3.3 volt regulated supply. A 19OmAh battery provides more than one hour of operation. The DSP chip 54 in this example is programmed to sample sensor signals at the following rates and resolution:

• ECG: 100HZ, 8 bit;

• vertical accelerometer (Ace Y): 100Hz, 8 bit;

• left/right accelerometer (AccX): 100Hz, 10 bit, and only the maximum and minimum per second are stored;

• forward/back accelerometer (AccZ): 100Hz, 10 bit, and only the maximum and minimum per second are stored;

• breathing signal: 20Hz, 8 bit;

• temperature: IHz, 10 bit; and, • perspiration IHz, 10 bit.

The DSP chip 54 also reads the unique serial number from the XBee chip on the patch.

Between ¹A - I second, the data is collated into packets for onward transmission. The DSP is programmed via its programming port after assembly but prior to final testing, and the security port is then locked so that the programmed code cannot be extracted. The microprocessor system will only allow access to the program memory for a complete memory update of the code.

Communication Protocol In this example a skin patch 10 is attached to the chest of a number of team players during a competitive event. An electrolyte electrode gel is used between the electrodes and the skin surface to make a good electrical contact. A double coated medical pressure sensitive polyethylene foam is used to adhere the patch to the skin.

The communications protocol involves the following functionality: The patch transmits an initial message including the unique serial number, and afterwards repeats this message at random intervals to avoid collisions with transmissions from other patches.

A base station 100, which in this example comprises an XBee evaluation board programmed with C++, receives the transmissions from the patches and converts the received RF data into a serial signal. The base station 100 assigns a player number to each serial number it receives and transmits these to the patches. Each patch then stores the player number that corresponds to its serial number. The base station is operated to assign player names and photos to the player numbers. The functional interrelation of the elements mentioned so far is illustrated in Fig. 2. When all the patches are identified, timing information is sent from the base station that determines the length of the window each patch has to send its data and the frequency with which the patch should expect timing beacon transmissions. The frequency is adjusted to balance timing accuracy against power consumption.

The beacon contains a message that realigns the counter on each patch. The beaconing system is used to eliminate problems that may arise due to clock inaccuracies on the patches. At receipt of the beacon the patch sets its time to zero. Subsequently, at a time calculated from the player number of each patch and the length of the transmission window, each patch transmits the previous second's data in a series of packets. Each packet includes a delimiter, message id, player id, the data and a checksum to check for packet errors. The transmitter 50 is put to sleep after each transmission and woken before the next beacon is expected; to conserve power. At the base station a user selects "start" to send a first beacon to the players' patches. As each packet is then received it is checked for the correct identity and checksum. The packets are then reformatted into bio-activity signals with the data being translated for display in graph format. Each player's graphs are displayed on separate pages and the mouse is used to click between the players; an example is shown in Fig. 3. The graphs shown in Fig. 3 can be scrolled in time and enlarged in amplitude, the graphs may also be stopped and started, however in general only the preceding sixty seconds of data are shown. Data can be copied from the graphs.

During a match the live data streams are displayed in real-time in high contrast graphs so they can be view outside by the playing field. In general the scale, offset, colour and other plot settings are user selectable. Sections of the graphs can be replayed using video style controls (pause, play, stop, skip forward, skip backward, skip to start/end etc.) The data may be saved to a compressed (zip) file. In addition various analysis techniques may be provided in software, for instance to display a scatter plot of accelerometry data to reveal trends and outliers; Fig. 4 is an example of a screenshot from such a live system.

Data transmitted to the patch can be stored in the patch memory until such time as it is down loaded to a PDA, Cell phone, Data Logger or similar portable device.

The generated data may be displayed to coaching or medical staff to increase the effectiveness of training. Alternatively, or in addition, the information may be transmitted to spectators to increase their sense of participation and involvement in the event.

User Interface A graphical user interface (GUI) is designed for each application. In general the applications use iconic representations of the players, charts and graph controls, timeline annotations, data logging and session data file compression, archival and retrieval.

A team view is shown in Fig. 5 with photographs and statistics of each player in the team; icons on the left hand side are used to switch views. The top icon selects the team view, and the next icon selects a single player's summary details, as shown in Fig. 6. In this view the following player details and parameters are displayed:

• photo;

• name; • number;

• weight;

• height;

• percentage of maximum heart-rate;

• fatigue index; • time in speed-zone one;

• time in speed-zone two;

• time in speed-zone three;

• time accelerating in speed-zone one;

• time accelerating in speed-zone two; • time accelerating in speed-zone three;

• total distance travelled;

• percentage hydration;

• low intensity body impact count;

• medium intensity body impact count; and, • high intensity body impact count.

Several screens can be shown simultaneously in a split screen broadcast format, as seen in Fig. 7. Custom made meters can be added to provide particular statistics, like the fatigue gauge shown in Fig. 8.

Nano-technology sensors

The implanted sensor itself is fabricated from nano-molecular porous silicon.

The implanted sensor operates by changing its reflective qualities in dependence on predetermined physiological changes. The implanted sensor is multi-functional; incorporating detection, measurement and communication devices. The implanted sensor is biocompatible, non-toxic and has a dynamic measurement range suitable for the detection of lactate levels in blood. This battery- free device operates via its enzyme-functionalized porous silicon particle matrix to continually generate a spectral reflectance that correlates to changes in blood lactate concentration levels. The biosensor's reflectance readings are interpreted via the readout system. The lactate measurements can determine the stress exerted on the muscles during activity, evaluate the limits of aerobic metabolism and inform about the healing process after a sustained injury. The development of the biosensor platform for lactate involves the following:

(i) Identifying optimum lactate recognition system strategies for surface immobilisation. Specifically, lactate level may be determined from one or more of the following: lactate dehydrogenase (LDH), which is an enzyme that catalyses the conversion of lactate to an output of the metabolism of glucose known as pyruvate; and lactate oxidase (LOD), which is an enzyme that catalyses the conversion of lactate to pyruvate via oxidisation.

Surface immobilisation may employ techniques such as chemical activation and grafting and functionalised plasma polymer layer.

(ii) Performing surface immobilisation of sensor to non-porous silicon substrate using surface characterisation techniques such as Fourier Transform Infra Red (FTIR), X-ray Photoelectron Spectroscopy (XPS) and Time-of-Flight Secondary Ion Mass Spectrometer (ToFSIMS) to quantify immobilisation efficiency.

(iii) Quantifying lactate sensing properties such as kinetics of lactate binding, efficiency of lactate binding, lactate detection limit, lactate dose response, reproducibility of response and interference level. (iv) Determining the performance of the lactate biosensor via simulations in body fluids to measure these properties, identify potential interfering molecules or proteins and identify the lifespan of the sensor.

(v) Optimising surface immobilisation of "sensor" based on the measured sensing properties by, for example, incorporating a polyethylene glycol (PEG) linker in the sensor for optimal enzyme recognition and introducing non-fouling coating to reduce interference and biofouling. Nanocrystalline porous silicon films are ideal hosts for detecting chemicals because of their large internal surface area and unique optical properties. Porous silicon functions as both matrix and transducer and a number of mechanisms are available. The luminescence of n-type porous silicon for instance is altered upon incorporation of molecules in the porous layer. Another approach is to use the porous interference layer for optical interferometric sensors. Molecular recognition events can be monitored by a shift in the Fabry-Perot fringe pattern as binding of analytes leads to an increase in effective optical thickness of the porous matrix of the silicon semiconductor. Using interferometric reflectance spectroscopy, biomolecules like streptavidin, immunoglobulines, desoxyribonucleic acid (DNA) and even bacteria have been detected in micromolar concentrations. These sensors yield linear signal-response curves and their sensitivity is limited.

A fluorescence biosensor using suspended lipid bilayers on porous silicon to detect individual endothelial cells. Another mechanism for DNA detection uses an interferometric biosensor based on p-type porous silicon. Namely, the hybridization of negatively charged DNA to its complementary strand, immobilized onto the surface, induces the corrosion of the porous interference layer, which now serves as matrix, transducer and signal amplification stage. A mechanism for porous silicon degradation involves a synthetic hydrolysis catalyst and enzymes. In more detail, the biodegradable sensor consists of particles of porous silicon, which only reflect light at a particular wavelength. These so-called Bragg mirrors consist of a multi-layered stack of high and low porosity layers of porous silicon. The periodicity gives rise to a photonic bandgap, in which propagation of light is forbidden and the light is completely back-reflected. These particles are functionalised with enzymes (lactate oxidase or lactate dehydrogenase). Turnover of the substrates by these enzymes results in changes to the porous silicon matrix, which in turn changes the peak reflectance wavelength. The change of the reflectance peak is proportional to the amount of analyte or in a flow situation, the rate of the peak shift can be related to the concentration of analyte. The reflector particles can be easily and painlessly embedded underneath the skin. The particles degrade over time (days-weeks) so explantation is not necessary. The particles can be placed at different sites of the body.

Hormonal Sensor

A hormonal sensor may also be used in conjunction with the patch to transmit hormonal parameters of a subject to the patch, or the base station, in real time. The hormonal sensor may be used in vivo or ex vivo. Key performance-indicating biomarkers or hormonal parameters are: • free testosterone;

• Cortisol;

• estradiol;

• progesterone;

• growth hormone (GH); • insulin-like growth factor 1 (IGF-I);

• luteinising hormone (LH); and

• prolactin (PRL).

The platform for sensing and transmitting signals of athletic performance-related biomarkers or hormones is known as a biodiagnostic platform; the platform comprising the following: a detection platform for surface chemical sensing; and if the sensor is used in vivo, a remote sensing platform to transmit hormonal parameters out of body to the patch or to the base station.

Development of an effective surface chemical sensing system involves the following steps: identifying and selecting suitable receptors for specific biomarkers; establishing a receptor-substrate attachment strategy considering highly sensitive surface analytical techniques such as Surface Plasmon Resonance (SPR) and the Quartz Crystal Microbalance (QCM) to establish surface immobilisation methodologies for the receptors of each biomarker; and optimising sensing performance considering sensitivity, detection limits, potential interferences and sensor lifespan.

Complex Motion Analysis (CMA) System A range of such separate sensors could be deployed at chosen locations around an athlete's body, say, to monitor status or performance at those locations. For example, RF sensors may be used in conjunction with the patch 10 to form a CMA system. This system involves the use of embedded RF sensors in sporting equipment or product used to track and transmit movement data in real time. For example, a CMA system may comprise a player wearing a smart sensor patch; RF sensors embedded in the player's clothing, tennis racquet and tennis ball; and a base station in communication with the patch and RF sensors. The embedded sensors in the tennis racquet track movement data such as force of impact, racquet head speed and 3D or 9D motion. The RF sensor in the tennis ball records movement parameters such trajectory path, location, rotation, impact, spin, force of impact and altitude.

The embedded and patch sensors then transmit separate streams of data to the base station. The base station may then store the data in a database and analyse and correlate the to produce very detailed body movement.

Ear Unit

Other, separate, external bio monitoring devices may also be used in conjunction with a patch. For example, the patch may be in communication with an ear unit comprising: a tympanic temperature probe to measure brain temperature from the tympanic membrane; and an ear pulse oximeter to measure oxygen saturation or SAO2. The ear unit may be held in place by means of ear moulding material and shaped and sized to be placed in the ear canal or on the ear lobe of a subject. Factors such as reliable placement, user comfort and accurate measure contribute to the selection of the ear moulding material. The ear unit may further comprises an electronic processing module and a signal processing module to enable RF communication with the patch or base station. A readout system that may be separate from readout system 40 is be placed on the patch to interrogate and communicate with the ear unit. Alternatively, the signal processing module may be placed on the patch instead on the ear unit.

The signals received from the ear unit may be calibrated to take into account noises caused by ambient conditions and motion.

Additionally, the ear unit may further comprises a blood oxygen, lactate or glucose sensor to read the oxygen level, and then transmit data wirelessly to the patch, or to the base station.

Product Packs

A variety of different commercial product packs may be made available, comprising more than one of the skin patches and a base station programmed to identify and receive data transmissions from each of them. bioTrainer™ product kit is specifically designed for coaching elite sports teams. The product kit consists of:

• one patch;

• one battery charger; • one data logger;

• one packet containing 20 adhesive backings (consumables);

• one radio frequency receiver & USB cable;

• one security protection dongle (prevents unauthorized use of the software);

• standard software CD & content CD; • instruction booklet;

• one remote control to remotely manage display and execute commands during use; and,

• one USB infrared receptor to connect the remote control to a PC.

A basic version of this product provides real-time biotelemetry including medical grade ECG, heart rate, dehydration, respiration, surface and core body temperature and detailed movement in three-axis from one body location in a non- restrictive and real-time manner. A basic video analysis system is also provided. Up to

3 extra patches can be added to the system based on the basic version. It has an outdoor range of approx ³A of a mile and indoor, 1/3 of a mile coverage.

Benefits include the delivery of multiple physiological data which can be used to identify if an athlete is fatigued or needs recovery time, has sustained critical force- of-impact damage, is performing above or below defined benchmark parameters. The system is also able to identify work rate measurements or severe medical/fitness related problems, and it can record the data in either a real-time or a programmed off-line data logged format. The information will provide the basis for building standard player databases benefiting training and game environments. Data obtained from the system can be used to identify warm-up sessions, player preparation and player physiology. It can also be used during air travel to map flying conditions on players.

A "Professional" version offers additional functionality, for instance it allows a user to obtain data from up to 50 athletes simultaneously via a networked system which can be accessed by various authorized users. It allows extended coverage to various locations with the use of multiple receivers. A professional video analysis system with

4 video inputs can be used, and the system also interlinks with an Environdata Weathermaster Satellite System providing Global Solar Radiation, Relative Humidity and Air Temperature and other atmospheric conditions. Both of these products have patches that include a miniaturized real-time Global

Positioning System (GPS) capable of locating a target to within 1 inch.

SportsTrac™ Media product is designed particularly for television coverage of sports events, to improve viewer enjoyment and engagement in telecasts.

Although the invention has been described with reference to a particular example, it should be appreciated that many variations and modifications are possible. For instance, in addition to wearing a patch, several separate sensors could be arrayed on the calf muscle of an athlete experiencing injury in that muscle. These sensors would be able to monitor the current status of the muscle in detail and transmit that data either to the patch or directly to a base station. Such an arrangement could be used to provide benchmark data from important muscles or groups of muscles while the athlete was fit for use in remediation after injury. Although the invention has been described with reference to application to humans involved in team or individual sports, it should be appreciated that it may be applied in many other situations, including:

• disaster sites; • hospital triage;

• healthcare;

• aged care;

• home healthcare;

• monitoring daily living, such as for falls and abnormal behaviour detection; • well-being and fitness;

• military; and

• emergency services.

It should also be appreciated that the technology could be applied to animal care, training or performance. Such a system could be used with animals involved in performance related or hazardous pursuits, for instance race horses would be monitored before during and after racing, and the data could be provided to spectators.

Claims

1. Apparatus for the capture and transmission of bio-activity data from an active animal subject, comprising: a flexible adhesive skin patch having mounted on it at least one physical sensor to generate data relating to one or more physical change concerning the subject in realtime, and a readout system to interrogate an implanted biodegradable passive sensor and generate data from it in real-time; an identity tag able to generate identity data; and, a transmitter to transmit the generated data to a base-station in real-time.

2. Apparatus according to claim 1, further comprising at least one physiological sensor mounted on the patch and able to generate data relating to one or more physiological change in the subject in real-time.

3. Apparatus according to claim 1 or 2, further comprising a remote display to display data received at the base-station.

4. Apparatus according to any preceding claim, wherein the apparatus is used to monitor military personnel, old people or animals.

5. Apparatus according to claim 1, wherein the flexible adhesive skin patch comprises a moulded elastomer.

6. Apparatus according to claim 1, wherein the flexible adhesive skin patch comprises a surgical foam adhesive pad.

7. Apparatus according to any preceding claim, wherein the patch is worn on the skin.

8. Apparatus according to any one of claims 1 to 6, wherein the patch is integrated into clothing, accessories or equipment carried by the subject.

9. Apparatus according to any preceding claim, wherein cut-outs are made in the patch to allow electrodes mounted on the back of the patch to contact the skin.

10. Apparatus according to claim 9, wherein, in use, a conductive electrolyte gel is placed on the patch electrodes to provide good electrical contact with the skin surface.

11. Apparatus according to any preceding claim, wherein the edges of the patch include slots to allow for the escape of perspiration.

12. Apparatus according to any preceding claim, wherein a double-sided medical grade pressure sensitive adhesive foam is used to interface between the patch and the skin.

13. Apparatus according to any one of claims 1 tol 1, wherein a soft skin adhesive is used to interface between the patch and the skin.

14. Apparatus according to any preceding claim, wherein the skin patch and sensors are fabricated in the form of a disposable single use sticking plaster.

15. Apparatus according to any preceding claim, further comprising a source of electrical power.

16. Apparatus according to claim 2, wherein the one or more physiological sensors measure one or more of the following: body temperature, including core, skin and environmental temperature; muscle activity and fatigue; perspiration rate, volume and content; body dehydration; heart rate and activity; breathing rate, depth and activity; blood oxygen, carbon dioxide, carbon monoxide and other blood gas levels; blood lactate, adrenalin, Cortisol and glucose levels; blood flow rate and blood perfusion;

Electro-cardiogram (ECG); and, Galvanic skin response (GSR).

17. Apparatus according to claim 1, wherein the one or more physical sensors measure one or more of the following: position (location); body movement,; direction of movement (up or down, left or right, posterior or anterior, as well as number of steps and cadence); body rotation; speed; acceleration and deceleration; and, impact and force of impact.

18. Apparatus according to any preceding claim, further comprising a push button contact on the patch to activate a personal distress alarm, or for acknowledgement signalling.

19. Apparatus according to any preceding claim, wherein the implanted biodegradable passive sensor is one or more subcutaneous injected Nano-sensors, and the readout system comprises a laser diode and optical sensor to interrogate an implanted sensor.

20. Apparatus according to any one of claims 1 to 18, wherein the implanted biodegradable passive sensor is one or more subcutaneous injected Nano-sensors, and the readout system includes a charge-coupled device (CCD) to provide a single wavelength light that will evoke a response from the biosensor.

21. Apparatus according to any preceding claim, further comprising the implanted sensor.

22. Apparatus according to claim 21, wherein the implanted sensor measures one or more of: body temperature, including core, skin and environmental temperature; muscle activity and fatigue; perspiration rate, volume and content; body dehydration; heart rate and activity; breathing rate, depth and activity; blood oxygen, carbon dioxide, carbon monoxide and other blood gas levels; blood lactate, adrenalin, Cortisol and glucose levels; blood flow rate and blood perfusion;

Electro-cardiogram (ECG);

Galvanic skin response (GSR); changes in blood pH; presence of, or changes in concentration of, preselected DNA molecules; presence of, or changes in concentration of, transition metal complexes; presence of, or changes in concentration of, preselected enzymes; presence of, or changes in concentration of, preselected antigens; presence of, or changes in concentration of, preselected antibodies; presence of, or changes in concentration of, preselected proteins; presence of, or changes in concentration of, glucose; presence of, or changes in concentration of, urease; and, presence of, or changes in concentration of, ferrocene.

23. Apparatus according to any preceding claim, further comprising an additional readout system mounted on the patch to communicate with ingestible core body temperature pill swallowed by the subject.

24. Apparatus according to any preceding claim, further comprising an additional readout system mounted on the patch to communicate with an ear unit comprising a infrared tympanic temperature probe that is placed in the ear canal, and an ear pulse oximeter that is placed on the ear lobe of a subject.

25. Apparatus according to any preceding claim, further comprising one or more hormonal sensors to identify one or more of: free testosterone; Cortisol; estradiol; progesterone; growth hormone (GH); insulin -like growth factor 1 (IGF-I); luteinising hormone (LH); and prolactin.

26. Apparatus according to any preceding claim, further comprising a complex motion analysis system involving embedded RF sensors in equipment or accessories to track and transmit movement data in real time.

27. Apparatus comprising more than one skin patch according to any preceding claim and a base station programmed to identify and receive data transmissions from each of them.

28. Apparatus according to claim 27, wherein the data transmissions are used for one or more of the following purposes: training, for instance of athletes; monitoring, including for performance, health and wellbeing; duty of care, for instance athlete impacts or exposure to hazardous environments or toxic substances entertainment, including sports television where one or more athletes' data may be provided in real-time as a overlay or tile screen insert;

Key Point Index (KPI) benchmarking; research; and direct feedback, for instance athletes may access their own transmissions.

29. A method for capturing bio-activity data from an active animal subject, comprising the following steps: collecting data from a flexible adhesive skin patch according to any one of claims 1 to 26; interrogating an implanted biodegradable passive sensor and generating data from it in real-time; interrogating the identity tag able to generate identity data; and, transmitting the generated data to a base-station in real-time.

30. Software for operating the skin patch and performing the method defined by claim 29.